news
European Commission Alzheimer’s drug approval marks advancement for EU patients
Lecanemab is the only approved Aβ monoclonal antibody that highly binds to and clears toxic protofibrils with high selectivity.
List view / Grid view
Drug Safety
news
NICE recommends new combination breast cancer drug
The agency’s recommendation could provide eligible breast cancer patients with a treatment that analysis suggest is to likely to work as well as two medicines already recommended by NICE.
news
GSK to advance antibody medicines for neurodegenerative diseases
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
news
Sampling system offers unique strategy for airborne bacterial detection
The proposed technique holds value for real-time monitoring and surveillance of airborne bacteria with high sensitivity and rapid results, the study showed.
article
The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
news
EMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
news
Shift to automated and sustainable options shaping environmental monitoring market
Addressing key challenges in the pharmaceutical and biotechnology environmental monitoring market, such as high technology costs, while leveraging key market drivers is critical for the sector to thrive, analysis suggests.
news
FDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
news
Optimal biosafety cabinet cleaning strategy proposed
The research highlights a potential approach to address cross-contamination challenges during cell-processing operations.
news
Drug for rare form of Alzheimer’s “scientifically promising”
The anti-amyloid drug study highlights the importance of longer-term follow-up to determine benefits and risks of dementia treatments.
news
European Commission approves Rytelo for LR- MDS-related anaemia
The European marketing authorisation offers a new treatment option for patients with transfusion-dependent anaemia in lower-risk myelodysplastic syndromes (LR-MDS), who are unresponsive to erythropoiesis-stimulating agents.
news
NICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
news
Investigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
news
Alzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
news
CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
